Management of Reflux After Sleeve Using Stretta

Morbid Obesity Clinical Trial

— MaRSS  

Official title:

Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02637713
• Other study ID #: 2015-5661a
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2019

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

Description:

Gastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.

A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients >18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.

The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)

2. On a PPI with GERD-related symptoms

3. On a PPI but like to discontinue them

Exclusion Criteria:

1. Age <18 or > 80

2. History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.

3. Unable or unwilling to consent for an invasive procedure.

4. History of intestinal leak after surgery.

5. History of revisional bariatric surgery

6. Significant sleeve abnormalities such and twist or large fundus

7. Hiatal hernia(>2cm)

8. Pregnancy

9. Inability to comply with study protocols and procedures

10. Esophageal stricture, Eosinophilic Esophagitis or Achalasia

11. Prior esophageal surgery or therapy for Barrett's Esophagus

12. Grades 3 or 4 esophagitis

13. Gastric or esophageal varices

14. History of obstruction of the small bowel or inflammatory bowel disease

15. Pacemaker or implanted cardiac defibrillator

16. Coagulopathy or use of anticoagulants

17. ASA classification >3

18. Scleroderma or other connective diseases

19. Use of immunosuppressive medications.

Related Conditions & MeSH terms

• GERD
• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• Stretta
Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.

Procedure:
• Radiofrequency (RF) Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic Health System	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Duke University Health System	Durham	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Houston Methodist Hospital	Houston	Texas
United States	Memorial Hermann-Texas Medical Center	Houston	Texas
United States	Gastroenterology Clinic of Acadiana	Lafayette	Louisiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	6 months
Primary	Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	12 months
Primary	Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score	RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.	24 months
Primary	Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	6 months
Primary	Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	12 months
Primary	Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score	GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.	24 months
Secondary	Esophageal pH Levels	All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation.	Baseline
Secondary	Esophageal pH Levels	If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.	6 months
Secondary	Esophageal pH Levels	If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.	12 months
Secondary	Use of Anti-reflux Medication	The number of patients using anti-reflux medications will be tabulated.	Baseline
Secondary	Cessation or Decreased Use of Anti-reflux Medication	The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.	6 months
Secondary	Gastric Emptying Study	A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (>50% retention at 4 hours) will be excluded from study	Baseline (up to 4 hours)
Secondary	Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy	If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.	6 months
Secondary	Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy	If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.	12 months
Secondary	EGD Abnormalities	An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology.	Baseline
Secondary	EGD Abnormalities	In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.	6 months
Secondary	EGD Abnormalities	In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.	12 months